Infographic: The new In Vitro Diagnostic Medical Device Regulation
The European Commission is working on drawing up new regulations for in vitro diagnostic medical devices. The new regulation is expected to have stricter requirements and will bring changes to the current approval procedures. The new EU In Vitro Diagnostic Medical Device Regulation (IVDR) will replace the EU’s current Directive on In Vitro Diagnostic Medical Devices (IVDD) (98/79/EC). The regulation applies to all IVD manufacturers who intend to place their IVDs in the EU. Find out more about the expected key changes and timeline in the new IVDR.